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England and Wales High Court (Queen's Bench Division) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Queen's Bench Division) Decisions >> Rich v Hull and East Yorkshire Hospitals NHS Trust  EWHC 3395 (QB) (24 November 2015)
Cite as:  EWHC 3395 (QB)
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QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| MISS MELISSA RICH
(a protected party by her Mother and Litigation Friend HELEN RICH)
|- and -
|HULL AND EAST YORKSHIRE HOSPITALS NHS TRUST
Philip Havers Q.C. (instructed by DAC Beachcroft LLP) for the Defendant
Hearing dates: 3rd-6th, 9th-10th November 2015
Crown Copyright ©
MR JUSTICE JAY:
Essential Factual Background
" no adhesions in abdominal cavity. Lower segment exposed and excised, thick, not vascular Liquor clear, no evidence of fresh abruption. Placenta complete, signs of old abruption on small surface "
The experts agree that on this occasion the lower segment of the uterus was thick, not thin in contrast with the operative findings when Adam was born. It is also agreed that the reference to "old abruption" must be to a relatively mild placental abruption during the course of this pregnancy.
"Well. Recurrent right abdominal pain under scar. To report stat[im] [i.e. immediately] if any acute onset pain with or without bleeding or if foetal movements decline sharply [or it might read "markedly"]."
Professor Purdie's letter to the GP reads:
" she continues to have recurrent lower right-sided abdominal pain, similar to the pain which she has experienced with her abruption and prior to her last emergency CS. There is no objective evidence of scar dehiscence, nor of abruption this time, but we will need to get a further scan done before she is reviewed in a week to check that there is no retroplacental collection.
She is aware of the need for a further section this time and that this may again be premature. Please let us know at any time should problems arise. She knows to report to you at once should there be an acute onset of abdominal pain with, or without, bleeding or should foetal movements rapidly decline Cons[ultant]/ S[enior] R[egistrar] only."
" now pain under all scar lying at home all day never goes out. Only up to toilet and children."
"Still c/o right iliac fossa pain. Probably adhesions ± old scar."
According to the letter Professor Purdie wrote to Helen Rich's GP on the same day:
"She is well but still has recurrent RIF pain which has caused such trouble during the pregnancy. Again, there is no clinical problem on abdominal examination today. The baby is well grown. Helen is normotensive and urine analysis is negative. I suspect that this is related to adhesions or to tensions of the old scar which, however, shows no sign of dehiscence. Should there be any acute onset of pain and/or bleeding she knows to report to you at once."
"Admitted with history of severe pain around the scar site, more on the right side of the lower abdomen at the right side of the scar pinky discharge previous two admissions with abdominal pain around scar site. Pain now much worse."
The Key Issues Arising
(i) should Professor Purdie have considered prescribing a course of corticosteroid drugs when he reviewed Helen Rich on 8th June 1993 (I focus on that date, and not on either of the May dates, because Melissa cannot succeed on causation had her mother received corticosteroids on one or other of those occasions); and, had he done so, would or should he have recommended corticosteroids?
(ii) on the balance of probabilities, would corticosteroid treatment on that date have avoided the RDS altogether or ameliorated it to such an extent that Melissa would have avoided PVL; or, alternatively, would have ameliorated it to a degree such that Melissa may properly claim that in law the entirety of her injury is attributable to the Defendant's tort?
A Brief History of Developing Clinical Practice in the Use of Corticosteroids
"This reduction is of the order of 40-60% and is independent of gender. Furthermore, the benefit of antenatal corticosteroids appears to apply to babies born at all gestational ages at which RDS may occur. While the greatest benefits are seen in babies delivered more than 24 hours and less than 7 days after commencement of therapy, babies delivered before and after this optimum period also appear to benefit the benefits of antenatal corticosteroids have been established. No further trials are necessary with the exception of certain specific situations or to establish other dosages or routes of administration."
"Recommended Drug Regimen
Betamethasone 4mg or Dexamethasone 4mg, twice a day for two days by intramuscular injection.
WE WOULD ENCOURAGE ALL OBSTETRIC UNITS TO CONSIDER THE USE OF SUCH THERAPY WHEN DELIVERY IS LIKELY BEFORE 34 WEEKS."
"The guidelines seemed to do the trick. Published in 1992, almost overnight they led to a huge change in medical practice. Bizarrely, though, doctors not only took up steroids but began to use higher or multiple doses, without any evidence that this was effective or safe "
"Every effort should be made to initiate antenatal corticosteroid therapy in women between 24 and 36 weeks' gestation with any of the following:
Threatened pre-term labour
Pre-term rupture of the membranes
Any condition requiring elective pre-term delivery [there was some discussion with Mr Hare as to exactly what this means, but ultimately it seems to me that I do not have to resolve this issue]
As pregnancy advances, the number of women that will have to be treated with corticosteroids to prevent a single case of RDS increases."
Fourthly, the guidelines set out a series of contraindications and precautions, none of which are relevant to Helen Rich's pregnancy. Fifthly, the dose and route of administration was "two doses of betamethasone 12mgs given intramuscularly 24 hours apart or four doses of dexamethasone 6mgs given intramuscularly 12 hours apart". Finally, the guideline included the following standard caveat:
"This guideline was produced under the direction of the SAC of the RCOG as an educational aid to obstetricians and gynaecologists. This guideline does not define a standard of care, nor is it intended to dictate an exclusive course of management. It presents recognised methods and techniques of clinical practice for consideration by obstetricians/gynaecologists for incorporation into their practices. Variations of practice taking into account the needs of the individual patient, resources and limitations unique to the institution or type of practice may be appropriate."
The First Issue: Breach of Duty
Corticosteroids: The Standard of Care in 1993
The Evidence of Professor Lilford and Mr Tyrrell
"One way of interpreting 'likely' is, a material risk of the birth taking place within the period of time the steroids are believed to be active. I would have recourse to how doctors generally make decisions: on the basis of a calculus, albeit intuitive, of the ratio of benefits to the risks."
"A. The particular case has more influence on the probability that pre-term labour may occur. The particular case has less bearing on whether or not you give the steroids, given the probability.
Q. Should it not all come down to the individual case?
A. This is the big question for evidence-based medicine. You must consider the average effect. It is a decision in the individual case informed by the epidemiology."
In re-examination, Professor Lilford was asked to clarify the somewhat gnomic terms of the first of his answers cited above, and he did so in this way. The determination of whether a degree of probability in an individual case has been attained is a matter of clinical judgment. Separately, the determination of what level of probability must exist before any particular treatment is warranted or mandated is determined by the evidence base as explained by any relevant guideline. The default assumption is that the clinician administers the recommended treatment unless there is a contraindication.
"The decision depends on the available evidence, the clinical findings and your experience. It is too simplistic to be prescriptive about this. In most cases, it is a matter of clinical judgment. If you believe that delivery is likely within the next 7 days, then steroids should be given I agree that a risk of 5-20% would have caused me to give very considerable thought to the use of steroids, but I would add to this that you need a clinical suspicion to give that number you need some evidence to support that view that you are likely to want to make a decision to carry out a CS, or some evidence that labour is about to happen. This must be part of the clinical picture." [here, I have amalgamated parts of Mr Tyrrell's cross-examination and re-examination, re-ordering his evidence as appropriate]
The Witness Statements of Professor Purdie
" My understanding is one might give steroids to mothers with babies prior to 32 weeks. Further, my use of the words, "may again be premature" [letter dated 18th May 1993] is quite distinct from me expressing any concern about whether there was a significantly increased risk of delivery before 32 weeks. After this point, my understanding is one gives surfactant and manages them in the neonatal period."
I asked Professor Purdie whether the reference to "32 weeks" was a typographical error, and he told me that it was not. I find this surprising, given that the SAC advice, which as an obstetrician with an academic background he must have known about, clearly refers to 34 weeks. It is quite true that the Liggins et al paper refers to 32 weeks, but subsequent literature goes up to 34 weeks if not beyond that. Furthermore, I am also surprised that Professor Purdie appears to believe that, given Helen Rich's history, there was no enhanced risk of delivery before 32 (or 34) weeks.
"In summary, I believe when I saw the Claimant's mother in May and June 1993 I would have considered, but rejected, steroids because I did not consider that premature labour with delivery before 34 weeks was likely. Even if I had considered using them I would not have done so unless and until delivery was imminent."
Professor Purdie's Oral Evidence
"There was a discussion in the department as to the triggering circumstances [this is my paraphrase]. There was a Consultants' meeting where the issue was discussed. I reviewed the literature, and came up with a set of indications:
- incipient pre-term labour [Professor Purdie explained elsewhere that there could be prodromal signs from which it could be deduced that the establishment of labour was to be anticipated]
- scar dehiscence
- antepartum haemorrhage
- membrane rupture
- elective pre-term delivery"
"In a patient with this history, premature delivery is always a possibility. In any consultation, the possibility of using steroids exists, in the background. I would only give active consideration, or bring the issue to the foreground, if the clinical situation mandated it; i.e. the occurrence of one of the complications of pregnancy which made delivery within 7 days likely."
"Pain from a uterine rupture does not settle. Pain from scar dehiscence continues, until delivery. We had no objective evidence of scar dehiscence at this point."
"My view on 8th June was that this was adhesion pain. Previous abdominal surgery is implicated in adhesions. The pain is RIF, not over the uterus and not over the position of the [uterine] scar. Pain was uniquely in the RIF. I had a suspicion that adhesions were the cause of the pain. It was not possible to get a clinical conformation of that. It is significant that it was not pain over the [uterine] scar."
The Expert Evidence of Mr John Hare FRCOG
"If only one dose was to be given, it should have been on 8th June. Apart from the incidents in April, there was an episode of pain in May which was worse on 19th May. At that point, she was given strong analgesia. On the following morning, she was complaining of less pain, but the scar was still tender. Tylex is prescribed [off licence] only if the pain is considerable. During that week, she was in considerable pain; she was virtually immobilised. This is highly indicative considerable pain, despite the Tylex. On 25th the Senior Registrar noted "now pain under all scar"; this could be a progression. He was unable to determine the presentation of the baby or the level of the presenting part. Almost certainly this was because the abdomen was too tender, and he couldn't palpate. On 8th June there was no record of tenderness. [Professor Purdie] has omitted to record the signs on palpation, or the state of the foetus. I cannot accept that the scar pain has gone away; it hasn't been recorded. She had been on strong analgesia for two weeks. Scar pain is a herald of dehiscence or rupture. These features mandated recognition of the likelihood, that is 10% risk, of delivery within 7 days."
In my view, this is the high watermark of Melissa's case on breach of duty and, should it arise, factual causation. There are three matters I need to add to the mix. First, Mr Hare is not requiring the presence of any specific clinical indication for delivery within the next 7 days. Instead, his approach involves looking at the presentation more broadly as was put in closing argument, more holistically. Given the past obstetric history, the longitudinal course of the index pregnancy, and the overall clinical picture on 8th June, the position had been reached whereby intervention became mandatory. Secondly, Mr Hare made clear elsewhere in his evidence that he did not accept that Professor Purdie's clinical note and GP's letter written on 8th June were comprehensive and/or accurate. However, he did accept that if these documents were taken at their face value then, without prejudice to his contention that none was required, on 8th June there was no specific clinical indication of delivery within 7 days. Thirdly, I did not understand Mr Hare to be abandoning his contention that it was sub-standard practice not to administer corticosteroids on 19th or 25th May. It was implicit from his extended answer to my question that the case for intervention was even stronger on 8th June.
The Expert Evidence of Mr Richard Porter FRCOG
"No it is for Professor Purdie to expand on this matter and specifically to address the implied assertion that he would only consider prophylactic antenatal corticosteroids if there were contractions."
I have no difficulty whatsoever with Mr Porter's "no" (which is correct), but in my view he should have commented on what he called Professor Purdie's "implied assertion". In his oral evidence, admittedly under considerable pressure from Mr Maskrey, Mr Porter tried to persuade me that the implied assertion he was referring to was that implicit in the Solicitors' question, not in paragraph 10 of Professor Purdie's witness statement. I regret to say that in my judgment Mr Porter was being disingenuous.
"Q. Leave these considerations aside (i.e. obstetric emergency] you should actively consider as part of your management plan (1) the fact that if she delivers without steroids you have lost the opportunity of reducing RDS by 50%, but (2) if you are using only one dose, and she does not deliver within the next 7 days, possibly 14, I have lost that opportunity?
A. I agree, but there should be some indication that what you are confronting is not just a theoretical possibility.
Q. Is an indication a clinical sign without which you don't act?
A. That is rather too global; but in relation to the specifics of this case, the answer is yes.
Q. Are you saying, that you must be confident that a woman is going into labour, or an obstetric emergency will arise leading to an immediate need for CS?
A. I take issue with "confident". We don't need that. What one has to have is some evidence, some individual findings, that lead you to believe that a potential risk has now crystallised into something more real. "More likely than not" is not what obstetricians think."
"The wound extends through several layers people can have abdominal pain because of multiple surgeries and not because of the uterine scar there are two conflicting interpretations of the presentation on 8th June. First, Mr Hare's the pain was referable to the uterine scar, although there was no sign of dehiscence. Secondly, consider the totality of the scar, i.e. from the skin down to the uterine muscle. There was no sign of dehiscence. This was not a surprising observation."
The Rival Contentions on Breach of Duty and Factual Causation
(1) the breach of duty was the failure to consider the prescription of steroids given the increased risk. This is a pure Bolam question, and Melissa's case is established on the expert evidence (provided, I would add, I reject Professor Purdie's unheralded oral elaborations of his witness statements).
(2) the next issue which arises is that of factual causation. Here, the governing law is set out in Bolitho v City and Hackney HA  AC 232. In that context, two questions arise: first, what would have happened had Professor Purdie not been in breach of duty; secondly, having answered the first question on the evidence, would that have been substandard practice [at 240G, per Lord Browne-Wilkinson]. Although I do not disagree with Mr Maskrey's formulation, the way in which I would prefer to express the Bolitho two-stage test is to ask first of all, what would have happened?; and then to ask, what should have happened?
(3) at the first stage of Bolitho, Mr Maskrey submitted that if I were satisfied on the balance of probabilities that this unit would have prescribed corticosteroids on 25th May, then I must proceed to the second stage and find that the practice at Hull was Bolam negligent.
(4) having so found, I must then ask myself the further second-stage question of what should have happened in this unit. If there is a range of clinical opinion as to what should have happened on 25th May, particularly given unit policy to prescribe only one course, I should move to 8th June and consider whether the prescription of corticosteroids was mandatory on that occasion, given Helen Rich's clinical presentation.
The First Question: Professor Purdie's Practice in 1993
The Second Question: what was the content of Professor Purdie's duty to Melissa on 8th June 1993?
"One tries to balance the benefits against the chances of the delivery not happening. This is a very difficult clinical decision, influenced by the clinical findings, the period of gestation, and other factors. I would be more inclined to give them at 28 weeks, when they might be inappropriate, then at 33 weeks, when the risk of RDS is lower."
Mr Tyrrell was not cross-examined further on this answer, in particular the last part of it. I accept that cross-examination was becoming difficult for Mr Maskrey because he was asking questions over the video-link to Queensland, Australia, and by this stage the picture had frozen. Nonetheless, the valid point that Mr Tyrrell was making was that the narrowing of the window of opportunity is paralleled, if not outstripped, by the diminution in the risk of RDS. This point was put in a slightly different way by the RCOG in its 1996 guideline ("as pregnancy advances, the number of women that will have to be treated with corticosteroids to prevent a single case of RDS increases").
The Third Question: was Professor Purdie in breach of his duty to Melissa on 8th June 1993?
The Fourth Question: Counterfactuals
"I have accepted that the RDS is the conduit through which the brain injury occurred here."
"A. Because her RDS was severe, it is not probable that it would have been ameliorated sufficiently to prevent the associated brain injury. We have looked at the Cochrane review and the sub-analyses. Because her RDS was severe, and it was the conduit through which the brain injury occurred, that illness would have had to have been avoided to avoid her brain injury I don't accept the premise that severity of RDS affects the cerebral blood flow.
Q. If you reduce the severity of the RDS, you are likely to reduce the severity of the blood flow [in the watershed areas of the brain]?
A. There is no scientific basis for that. I agree that RDS gives rise to hypoxia-ischaemia by virtue of changes in cerebral blood flow. But there is no scientific basis for the premise that the disturbances in cerebral blood flow are more severe when the RDS is more severe. This is not a justified inference, given the lack of data in any event which shows the link between RDS and PVL. Relatively mild RDS in a ventilated baby can cause blood flow changes."
The First Question: Would Maternal Corticosteroids have Avoided Melissa's RDS?
"Reduction in RDS is seen in infants born up to 7 days after the first dose. This review has not shown any benefit in primary outcomes for infants delivered greater than 7 days after treatment with antenatal corticosteroids. In fact, birthweight is reduced in this subgroup. This lack of benefit is not a new finding, and in the past has lead [sic] to the practice of repeating courses of antenatal corticosteroid weekly if women remain undelivered."
"We have included the results of the subgroup analysis in this update because we recognise that clinicians will want to see this information for its practical implications, and also because it has been the subject of much conjecture following the first review. Caution, must however, be expressed in the interpretation of the subgroup analyses conducted in this review. There is the possibility of Type 1 error due to the number of analyses conducted [i.e. because the numbers involved become quite small, the risk of wrongly concluding that the null hypothesis has been falsified increases]. Furthermore, the subgroups of gestational age at delivery, length of premature rupture of the membrane and entry to delivery interval, involve post-randomisation variables. Conducting subgroup analysis based on post-randomisation variables is liable to considerable bias as the variable on which the subgroup is based may be affected by the intervention that occurs at randomisation. The clinician should therefore not draw too many conclusions from the results of the sub-group analyses."
Analysis and Conclusions
"The authors of the paper do comment that although "the estimated pooled risk reductions did not reach statistical significance, patients and doctors may be reluctant to embark on a new trial that involves a placebo group." Translating that observation into the realities of scientific life means that it is very unlikely that there will ever be a research series carried out prospectively that will reveal to the 95% confidence limit whether Heparin does alter the outcome in these cases. As I observed during the hearing, given the perceived benefit of Heparin administration, it would almost certainly be regarded as unethical to develop a trial that involved some patients receiving Heparin and others not receiving it for the purposes of trying to see whether death or dependency is prevented by the administration of Heparin. The consequence of this is that if a court felt itself bound to act on evidence that demanded statistical cogency to a 95% confidence limit, no claimant negligently deprived of Heparin could ever succeed at the causation stage."
The Second Question: Would Maternal Corticosteroids have Ameliorated Melissa's RDS to the extent that she would not have developed PVL, alternatively did the Failure to Administer Maternal Corticosteroids Materially Contribute towards Melissa's RDS such that the Defendant is liable for all her Loss?
"But there is no scientific basis for the premise that the disturbances in cerebral blood flow are more severe when the RDS is more severe. This is not a justified inference, given the lack of data in any event which shows the link between RDS and PVL." [my emphasis]
" one cannot draw a distinction between medical negligence cases and others. I would summarise the position in relation to cumulative cause cases as follows In a case where medical science cannot establish the probability that 'but for' an act of negligence the injury would not have happened but can establish that the contribution of the negligent cause was more than negligible, the 'but for' test is modified, and the claimant will succeed." [paragraph 46]